A front page article in The New York Times (below) reports: "Bayer A.G., theGerman pharmaceutical giant, failed to reveal to federal drug officials theresults of a large study suggesting that a widely used heart-surgerymedicine might increase the risks of death and stroke, the Food and DrugAdministration."

Failure to disclose study findings to the FDA is a federal crime.

So what is preventing the U.S. Department of Justice from prosecuting Bayerfor manslaughter?

Why are pharmaceutical giants whose repetitive crimes of concealment haveresulted in hundreds of thousands of preventable deaths-allowed to continueto use their government license to engage in business as usual?

One primary reason-as confirmed in the scathing report by the Institute ofMedicine-safety is not a priority for the FDA which consistently shieldsthose whom FDA officials perceive as the agency’s paying "clients." Whereastaxpayers are treated with lethal drugs bearing FDA’s seal of approval,pharmaceutical and biotech companies receive the red carpet treatment–evenwhen they are caught selling lehtal drugs without warning.

The Times reports that despite Bayer’s failure to reveal the results:"Nevertheless, the agency did not change its advice about whether patientsshould be given the drug. Instead, it restated previous warnings thatTrasylol’s use should be limited to patients in whom the risks of blood lossoutweighed the drug’s risks."

The Times also reports: "Several members of the advisory committee that metlast week said they were shocked that Bayer failed to inform them of thestudy."

About as "shocked" as Claude Reins was when told there was gambling inCasablanca!

WASHINGTON, Sept. 29 – Bayer A.G., the German pharmaceutical giant, failedto reveal to federal drug officials the results of a large study suggestingthat a widely used heart-surgery medicine might increase the risks of deathand stroke, the Food and Drug Administrationhttp://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and_drug_administration/index.html> announced Friday.

Bayer scientists even appeared at a public meeting called by theF.D.A. on Sept. 21 to discuss the possibility that the drug, Trasylol, mighthave serious risks. But they did not mention the study or its worrisomeresults.

In a highly unusual move, the food and drug agency released a publichealth advisory saying it had learned of the study’s existence only onWednesday. Preliminary results of the study demonstrate "that use ofTrasylol may increase the chance for death, serious kidney damage,congestive heart failure and strokes," the advisory said.

Nevertheless, the agency did not change its advice about whetherpatients should be given the drug. Instead, it restated previous warningsthat Trasylol’s use should be limited to patients in whom the risks of bloodloss outweighed the drug’s risks.

Since then, members of Congress and even top scientific advisers haveconcluded that the F.D.A. lacks the regulatory authority and the moneyneeded to detect and protect against drug dangers.

Drug companies have also been sharply criticized for failing to makepublic the results of some human trials of their drugs that suggest that thedrugs are either ineffective or dangerous. Some lawmakers have proposedlegislation that would require that nearly all human drug trials must beannounced and their results disclosed publicly.

A top F.D.A. official said the agency learned of the Trasylol studyon Wednesday only after a getting a tip from a researcher involved in it.The official insisted on anonymity because of the sensitive nature of theinformation.

In a written statement, Bayer said "that it mistakenly did notinform" the F.D.A. of the study and added, "This data was not sharedimmediately with the agency because it was preliminary in nature."

Staci Gouveia, a Bayer spokeswoman, said the company nonethelessstood behind the safety of Trasylol, which has become one of Bayer’s fastestsellers. Sales last year were $200 million and were expected to nearlytriple this year.

Several members of the advisory committee that met last week saidthey were shocked that Bayer failed to inform them of the study.

"For them not to mention that it was under way, that it was beinganalyzed or that results were available is appalling and will do significantharm to their reputation for transparency," said Dr. John Teerlink, anassociate professor of medicine at the University of California<http://topics.nytimes.com/top/reference/timestopics/organizations/u/university_of_california/index.html> , San Francisco, and a member of the advisorycommittee.

"The safety of this drug is called into further question now," Mr.Findlay said.

Doctors give Trasylol to patients before surgery to reduce the risksof blood loss. It can also reduce the need for transfusions in patientsundergoing heart bypass surgery. Trasylol, also known as aprotinin, has beenon the market for 13 years.

But two recent studies suggested that the drug might have seriousrisks. One of the articles, published in January in The New England Journalof Medicine<http://topics.nytimes.com/top/reference/timestopics/organizations/n/new_england_journal_of_medicine/index.html > , found that the drug increases therisks of kidney failure, heart attack and stroke. The study concluded thathalting the drug’s use would prevent 10,000 to 11,000 cases of kidneyfailure a year and save more than $1 billion a year in dialysis costs, aswell as nearly $250 million spent on the drug itself.

There are other, cheaper drugs that can be used in Trasylol’s place.

Still, the advisory panel concluded that Trasylol’s risks were worthtaking in some patients. Dr. Teerlink said that despite the results of thenew study, that might still be true.

Bayer’s study was performed by a contract research organization. ButBayer did not inform the F.D.A. that the study was being done, even thoughthat is routine practice.

It examined hospital records of 67,000 patients, 30,000 of whomreceived Trasylol. The rest got other drugs. It concluded that the patientsgiven Trasylol were at greater risk.

Such studies, however, are fraught with statistical and otherproblems. Patients given Trasylol may have been sicker than those givenother drugs. Their worse outcomes would be explained not by problems withTrasylol but by their own illness.

Susan Bro, an F.D.A. spokeswoman, said it was evaluating the newstudy and would decide soon whether the results merit changing the agency’sadvice about use of the drug.

"It is regrettable that the F.D.A. advisory board did not have thebenefit of a frank scientific dialogue based on the totality of availabledata," she said.

Republican of Iowa and chairman of the Senate FinanceCommittee and a longtime critic of the F.D.A., said Bayer’s behavior provedthat the agency was largely toothless.

"The remedy is mandatory reporting of all clinical trials and realteeth for the F.D.A. to do its job in holding drug companies accountable,"Mr. Grassley said. Copyright 2006 The New York Times Company

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